CompletedPhase 1

Study to Evaluate Safety and Tolerability of XmAb13676 (Plamotamab) in Patients With CD20-expressing Hematologic Malignancies

United States, France, South Korea154 participantsStarted 2016-10

Plain-language summary

The purpose of this study is to determine the safety and tolerability of intravenous (IV) and subcutaneous (SC) administration of XmAb13676 and to determine the maximally tolerated dose (MTD) and/or recommended dose (RD).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Histologically confirmed diagnosis (specified by 2016 World Health Organization) of DLBCL or transformed low-grade lymphoma with measurable disease
. Patient must be refractory or have relapsed after 2 or more standard therapeutic options, at least one of which must have included anti-CD20 antibody therapy.
. Not a candidate for or refusing treatment with hematopoietic stem cell transplantation
. Diagnosis of follicular lymphoma Grades 1-3a
. Patient must be ineligible for or have exhausted standard therapeutic options and have had 2 or more prior systemic regimens.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety and tolerability as determined by the number of participants with treatment-related adverse events as assessed by CTCAE v4.03

Timeframe: Baseline Day 1 through Day 56

Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb13676 dosing

Timeframe: Baseline Day 1 through Day 56

Trial details

NCT IDNCT02924402

SponsorXencor, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04

View on ClinicalTrials.gov More B-cell Non-Hodgkins Lymphoma trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Histologically confirmed diagnosis (specified by 2016 World Health Organization) of DLBCL or transformed low-grade lymphoma with measurable disease
. Patient must be refractory or have relapsed after 2 or more standard therapeutic options, at least one of which must have included anti-CD20 antibody therapy.
. Not a candidate for or refusing treatment with hematopoietic stem cell transplantation
. Diagnosis of follicular lymphoma Grades 1-3a
. Patient must be ineligible for or have exhausted standard therapeutic options and have had 2 or more prior systemic regimens.

What they're measuring

Safety and tolerability as determined by the number of participants with treatment-related adverse events as assessed by CTCAE v4.03

Timeframe: Baseline Day 1 through Day 56

Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb13676 dosing

Timeframe: Baseline Day 1 through Day 56